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临床试验/NCT05809817
NCT05809817进行中(未招募)不适用

Economic Evaluation of the Current Proposal and Different Decision-making Scenarios of Coverage Increases of an Oral Health Policy for Patients With Type 2 Diabetes Mellitus in Chile: A Microsimulation Model Based on Real-world Data

University of Chile2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
135
试验地点
2
主要终点
Metabolic control

研究概览

简要总结

The goal of this study is to evaluate the cost-effectiveness of the current proposal and different decision-making scenarios of periodontal care coverage increases for patients with T2DM in Chile. The main objective of the clinical section of this study (effectiveness) aims to determine the effectiveness of periodontal care in patients with T2DM under follow-up in the Cardiovascular Health Program (Programa de Salud Cardiovascular, PSCV) of the in the CEMO Villa Sur of Pedro Aguirre Cerda and the CESFAM Antonio Varas of Puerto Montt.

A highly matched control group is proposed using Propensity Score Matching of PSCV patients with T2DM who have not received periodontal care. This would allow a better comparison of the individuals who will actually be treated against a counterfactual against of those with similar characteristics who did not receive periodontal intervention during the follow-up period of this first stage.

详细描述

Introduction

Oral diseases and type 2 Diabetes Mellitus (T2DM) constitute an important public health problem in Chile, due to their high prevalence and economic and social impact. T2DM increases the risk of oral diseases such as periodontitis, and the latter worsens the metabolic control of T2DM, increasing the risk of macrovascular and microvascular complications. More than 10% of total health spending in Chile is allocated to the treatment of T2DM, especially for the management of its complications. The main T2DM control program in Chile is the Cardiovascular Health Program (PSCV) that treats more than 900,000 people with T2DM, however, its results are still insufficient. Although periodontal treatment improves the metabolic control of T2DM, the proposed goal of periodontal care coverage for patients with T2DM in the context of the PSCV is only 2%. Therefore, the decision to expand periodontal care coverage to efficiently improve the health status of these patients is crucial.

Objective

To evaluate the cost-effectiveness of the current proposal and different decision-making scenarios for increasing periodontal care coverage for patients with T2DM from the perspective of the public health system in Chile.

Methods: In the first stage, a prospective observational cohort study will be conducted at the CEMO Villa Sur in Pedro Aguirre Cerda and at the CESFAM Puerto Varas in the commune of Puerto Montt to estimate treatment costs and the effectiveness of periodontal care on glycated hemoglobin (HbA1c) levels in the context of PSCV (real-world data). The intervention cohort will consist of those patients with T2DM receiving periodontal care during 2023, while the comparison cohort will consist of those on the waiting list during the same period, matched 1:1 through Propensity Score Matching. In a second stage the costs and effects of each coverage alternative (2%, 20%, 40%, 60%, 80% and 100%) will be modeled using microsimulation techniques to estimate the projected impact over a lifetime horizon of HbA1c changes on the risk of complications, death and decreased quality of life. Costs for each clinical stage will be obtained from national GES (Explicit Health Guarantees) cost estimates, supplemented by other sources, and quality-adjusted life years will be used as a summary measure of effects. Costs and effects will be combined to estimate the incremental cost-effectiveness ratio (ICER). From the probabilistic sensitivity analysis, acceptability curves and frontiers and expected loss curves for the proposed courses of action will be estimated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Metabolic control

时间窗: Baseline and 3 months after periodontal treatment

Mean change from baseline HbA1c at 3 months after periodontal treatment

次要结局

未报告次要终点

研究者

发起方
University of Chile
申办方类型
Other
责任方
Sponsor

研究点 (2)

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